Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02002598|
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bendamustine Drug: Carfilzomib Drug: Dexamethasone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 1, 2019|
|Actual Study Completion Date :||March 1, 2019|
Experimental: CFZ with bendamustine and dexamethasone
Subjects will receive Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days with dose escalation from 27, 36, 45 to 56 mg/ m2 . No matter what target dose the subject will receive, days 1 and 2 doses in the first cycle will always be 20 mg/m2, followed by target dose for all subsequent dates and cycles. Bendamustine will be given IV on days 1 and 2 with dose escalation up to 90 mg/m2 and dexamethasone 20 mg orally or intravenously on 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first.
Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle.
Dose escalation is as follows:
-1 | 60 mg/m2
Other Name: Treanda
Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days.
Dose Escalation is as follows:
-1 | 27 mg/m2
Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.
- Maximum Tolerated Dose (MTD) of Carfilzomib in combination with bendamustine and dexamethasone [ Time Frame: 6 months ]The primary endpoint of this study is dose-limiting toxicity (DLT), to define the recommended phase II dose.
- Overall response rate (ORR) [ Time Frame: 2 years ]Includes complete response and partial response.
- Duration of response (DOR) [ Time Frame: 2 years ]The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded since the study treatment started).
- Progression free survival (PFS) [ Time Frame: 2 years ]PFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.
- Time to best response [ Time Frame: 2 years ]Time to the best response recorded.
- Overall survival (OS) rate [ Time Frame: 2 years ]The percentage of people who are still alive.
- Number of adverse events (AEs) [ Time Frame: 2 years ]Total number of AEs observed.
- Number of adverse events in relation to carfilzomib maintenance [ Time Frame: 2 years ]Total number of AEs observed that are determined to be related to carfilzomib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002598
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Siyang Leng, MD||Columbia University|